Document text
Page 1 of 488
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE
3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833560
Page 2 of 488
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/17/2020
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833561
Page 3 of 488
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12521010]
2.Birth Date: /1939
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833562
Page 4 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/17/2020
2.Erroneous Visit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833563
Page 5 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833564
Page 6 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833565
Page 7 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: Apr/18/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vertigo]
Start Date: Oct/2/2019
Ongoing: YES
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833566
Page 8 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Aug/17/2020
2.Weight: [165.0]
3.Unit: LB
4.Height: [63.0]
5.Unit: in
6.Body Mass Index: [29.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833567
Page 9 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/17/2020
2.Randomization Number: [230749]
3.Randomization Group: [ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833568
Page 10 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNWG1K]
5.bSample ID [BNWG1L]
5.cSample ID [BPYXM0]
5.dSample ID [BPYXM1]
5.eSample ID [BPYXM2]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833569
Page 11 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYXLZ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833570
Page 12 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/17/2020 15:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833571
Page 13 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833572
Page 14 of 488
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833573
Page 15 of 488
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833574
Page 16 of 488
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833575
Page 17 of 488
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833576
Page 18 of 488
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYXZK]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833577
Page 19 of 488
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/8/2020 10:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833578
Page 20 of 488
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833579
Page 21 of 488
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833580
Page 22 of 488
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833581
Page 23 of 488
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/5/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYY1Y]
5.bSample ID [BPYY1Z]
5.cSample ID [BPYY20]
5.dSample ID [BNWG3X]
5.eSample ID [BNWG3Y]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833582
Page 24 of 488
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833583
Page 25 of 488
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833584
Page 26 of 488
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833585
Page 27 of 488
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833586
Page 28 of 488
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833587
Page 29 of 488
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833588
Page 30 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/25/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833589
Page 31 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/25/2020
2.Date of First Symptom Started: Dec/25/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/26/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833590
Page 32 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Symptoms - Other
5.aSymptoms - Other Text: [Chest congestion]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833591
Page 33 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Co
llectionSpecimen Typ
eSpecimen Collect
ion LocationAssay Code and Description Device TypeForm Instan
ce
1.Dec/25/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833592
Page 34 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/25/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ABBOTT DIAGNOSTICS ID NOW COVID-19
7.Test Result: POSITIVE
8.Comments/Findings/Details: [Hospital reported that the nasal swab came back positive.]
9.Trade Name Other, Specify: [ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833593
Page 35 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Subject went to hospital emergency and never was able to do a SELF SWAB
HOME KIT. The subject passed!]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833594
Page 36 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Hospital did a Nasal Swab when subject was admitted. The kit used was ABBOTT
ID NOW SARS-COV-2 POINT OF CARE according to medical records. The site
never collected a Nasal Swab or a Self Nasal swab.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833595
Page 37 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833596
Page 38 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Dec/25/2020 NO
Discharge Date:
Dec/26/2020
Repeating Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833597
Page 39 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Dec/25/2020
4.Ongoing? NO
Discharge Date:
Dec/26/2020
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833598
Page 40 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Id
entifierCon Non-Drug Treatment
s Pre-specifiedTreatment TreatmentStart Da
teForm Instanc
e
1.1 YES HIGH FLOW OXYGE
N THERAPY HIGH FLOW OXYGE
N THERAPY Dec/26/2
020 Repeating
Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833599
Page 41 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1]
2.Concomitant Non-drug Treatment
Pre-specified:YES
3.Treatment: HIGH FLOW OXYGEN THERAPY
4.Treatment: [HIGH FLOW OXYGEN THERAPY]
5.Start Date: Dec/26/2020
6.Ongoing? NO
End Date:
Dec/26/2020
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833600
Page 42 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Pneumonia due to Covid 19]
Date of Diagnosis:
Dec/25/2020
3.Toxicity Grade: 5
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833601
Page 43 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinical Eve
nt:Subcategory of Clinical Event Diagnosis ObtainedToxicity Gr
adeForm Instance
1.SEVERE COVID-19 ILL
NESS SIGNIFICANT ACUTE RENAL DYSF
UNCTION YES
Diagnosis:
Acute kidney dis
ease
Start Date:
Dec/25/2020
Ongoing?:
NO
End Date:
Dec/26/2020
5 Repeating
Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833602
Page 44 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Illness Details
1.Category of Clinical Event: SEVERE COVID-19 ILLNESS
2.Subcategory of Clinical Event: SIGNIFICANT ACUTE RENAL DYSFUNCTION
3.Was a diagnosis obtained? YES
Diagnosis:
[Acute kidney disease]
Start Date:
Dec/25/2020
Ongoing?:
NO
End Date:
Dec/26/2020
4.Toxicity Grade: 5
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833603
Page 45 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for
Lab TestVendor NameCollecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
1.CLINICAL
CHEMISTR
Y McLeod Loris Hospital 3611
Mitchell Street Loris SC 295
69 Dec/25/
2020 BLOO
D Sponsor-Defi
ned Identifie
rTest:Res
ult:
329 C Reactive Prote
in_PX329 24.7
30 Alanine Aminotr
ansferase_PX30 [ ]
28 Aspartate Amino
transferase_PX2
8 [ ]
Alkaline Phosph
atase_PX35
21 Bilirubin_PX21 1.8
47 Blood Urea Nitr
ogen_PX47 91
48 Creatinine_PX4
8 4.15
Repeating
Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833604
Page 46 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Dec-2020 02:24
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
2. DELETED Sponsor-Defin
ed IdentifierTest:Res
ult:
C Reactive Protein
_PX329
30 Alanine Aminotran
sferase_PX30 [ ]
28 Aspartate Aminotra
nsferase_PX28 [ ]
Alkaline Phosphata
se_PX35
Bilirubin_PX21
Blood Urea Nitroge
n_PX47
Creatinine_PX48 Repeating
Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833605
Page 47 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [McLeod Loris Hospital 3611 Mitchell Street Loris SC 29569]
3.Collection Date: Dec/25/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [24.7]
Not Done:
LNMT Low
[0.0]
High
[1.0]
Unit
mg/dL
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833606
Page 48 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [ ]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [1.8]
Not Done:
LNMT Low
[0.1]
High
[1.2]
Unit
mg/dL
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833607
Page 49 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [91]
Not Done:
LNMT Low
[9]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [4.15]
Not Done:
LNMT Low
[0.66]
High
[1.25]
Unit
mg/dL
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833608
Page 50 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Incomplete, Data Complete, Deleted
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.aSponsor ID: [ ]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833609
Page 51 of 488
***Confidential***
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [ ]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [ ]
Test: Bilirubin_PX21
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5 fSponsor ID: [ ]
Test: Blood Urea Nitrogen_PX47
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
FDA-CBER-2021-5683-0833610
Page 52 of 488
***Confidential***
5.gSponsor ID: [ ]
Test: Creatinine_PX48
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
FDA-CBER-2021-5683-0833611
Page 53 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Not Applicable Not Applic
able Sponsor-Defined
IdentifierTest:Resu
lt:
Hemoglobin_
PX1
Hematocrit_P
X2
Erythrocytes_
PX3 [ ]
Platelets_PX5
Leukocytes_P
X7 [ ]
Neutrophils_P
X608
Eosinophils_P
X609
Monocytes_P
X612
Basophils_PX
610
Lymphocytes
_PX611 Repeating
Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833612
Page 54 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Dec-2020 02:28
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category fo
r Lab TestVendor Name (DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
2.HEMATOL
OGY McLeod Loris Hospital 3611 M
itchell Street Loris SC 29569 Dec/25/2
020 BLOOD
Sponsor-Defi
ned IdentifierTest:Res
ult:
1 Hemoglobi
n_PX1 9.2
2 Hematocrit
_PX2 27.6
3 Erythrocyte
s_PX3 [ ]
5 Platelets_P
X5 125
7 Leukocytes
_PX7 [ ]
608 Neutrophils
_PX608 5.4
609 Eosinophils
_PX609 0.3
612 Monocytes
_PX612 0.5
610 Basophils_
PX610 0.2
611 Lymphocyt
es_PX611 0.6 Repeating
Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833613
Page 55 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type:
Lab Result
5.aSponsor ID: [ ]
Test: Hemoglobin_PX1
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [ ]
Test: Hematocrit_PX2
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833614
Page 56 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: [ ]
Test: Erythrocytes_PX3
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [ ]
Test: Platelets_PX5
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [ ]
Test: Leukocytes_PX7
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833615
Page 57 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: [ ]
Test: Neutrophils_PX608
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [ ]
Test: Eosinophils_PX609
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.hSponsor ID: [ ]
Test: Monocytes_PX612
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833616
Page 58 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.iSponsor ID: [ ]
Test: Basophils_PX610
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.jSponsor ID: [ ]
Test: Lymphocytes_PX611
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833617
Page 59 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [McLeod Loris Hospital 3611 Mitchell Street Loris SC 29569]
3.Collection Date: Dec/25/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1] Comments
Test: Hemoglobin_PX1
Result: [9.2] Comments
Not Done: Comments
LNMT Low
[14.0]
High
[18.0]
Unit
g/dLComments
5.bSponsor ID: [2] Comments
Test: Hematocrit_PX2
Result: [27.6] Comments
Not Done: Comments
LNMT Low
[40.0]
High
[52.0]
Unit
%Comments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833618
Page 60 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [125]
Not Done:
LNMT Low
[150]
High
[450]
Unit
/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833619
Page 61 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [5.4]
Not Done:
LNMT Low
[1.9]
High
[7.6]
Unit
10^9/L
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.3]
Not Done:
LNMT Low
[0.00]
High
[0.50]
Unit
10^9/L
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.5]
Not Done:
LNMT Low
[0.2]
High
[1.5]
Unit
10^9/L
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833620
Page 62 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.2]
Not Done:
LNMT Low
[0.0]
High
[0.2]
Unit
10^9/L
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [0.6]
Not Done:
LNMT Low
[1.1]
High
[4.8]
Unit
10^9/L
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833621
Page 63 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
1.Dec/25/2020 Record Identifier: Systolic: Diastolic:
1 124 68 Repeating Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833622
Page 64 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
2. DELETED Record Identifier: Systolic: Diastolic:
1 Repeating Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833623
Page 65 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [124]
Diastolic: [68]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [79]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833624
Page 66 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25 Form Status: Incomplete, Data Complete, Deleted
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: //
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833625
Page 67 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
1.Dec/25/2020 Record Identifier: Oxygen Saturation
1 98.0 Repeating Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833626
Page 68 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Dec-2020 02:31
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
2. DELETED Dec/25/2020 Record Identifier: Oxygen Saturation
1 98.0 Repeating Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833627
Page 69 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/25/2020 Comments
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0] Comments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833628
Page 70 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Deleted
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/25/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0] Comments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833629
Page 71 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833630
Page 72 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833631
Page 73 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applic
able Repeating
Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833632
Page 74 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833633
Page 75 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Dec/25/2020 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
An enlarged heart
Repeating Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833634
Page 76 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Dec/25/2020 Comments
2.Location of Assessment: CHEST Comments
3.Type of Imaging Exam: X-RAY Comments
4.Assessment: ABNORMAL
If abnormal, specify findings:
[An enlarged heart]Comments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833635
Page 77 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/26/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/26/2020 Comments
2.Erroneous Visit ERRONEOUS VISIT Comments
COVID-19 Illness Visit
3.COVID-19 Illness Visit: Not Done Comments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833636
Page 78 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/26/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833637
Page 79 of 488
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833638
Page 80 of 488
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833639
Page 81 of 488
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833640
Page 82 of 488
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Dec/26/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833641
Page 83 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833642
Page 84 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833643
Page 85 of 488
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 Scalp Laceration Dec/8/2020 19:
05 NO
End Date Time:
Dec/8/2020 20:30
Repeating
Pages
2.ADVERSE EVE
NT 2 Pneumonia due to COV
ID-19 Dec/25/2020 22
:03 NO
End Date Time:
Dec/26/2020 09:55
Repeating
Pages
3.ADVERSE EVE
NT 3 Acute Renal failure Dec/25/2020 22
:03 NO
End Date Time:
Dec/26/2020 09:55
Repeating
Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833644
Page 86 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Scalp Laceration]
4.Start Date Time: Dec/8/2020 19:05
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/8/2020 20:30
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833645
Page 87 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833646
Page 88 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pneumonia due to COVID-19]
4.Start Date Time: Dec/25/2020 22:03
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/26/2020 09:55
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833647
Page 89 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Pneumonia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2020518879]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833648
Page 90 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Acute Renal failure]
4.Start Date Time: Dec/25/2020 22:03
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/26/2020 09:55
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Kidney damage]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833649
Page 91 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833650
Page 92 of 488
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryMedication E
rrorStart DateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1.Not Applica
ble Not Applicable
Not Applica
ble Not Applicable Not Applicable Repeating
Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833651
Page 93 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of
Medication Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still ongoing? Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication
given?Not Applicable Comments
7.Was a Non-Drug Treatment given? Not Applicable Comments
8.Did the Medication Error cause the
subject to be discontinued from the
study?Not Applicable Comments
9.Was this medication error associated
with any adverse events?Not Applicable Comments
10.Serious Adverse Event Number: For
Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833652
Page 94 of 488
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applic
able Repeating
Pages
2.Not Applicable Not Applicable Not Applicable Not Applicable Not Applic
able Repeating
Pages
3.Not Applicable Not Applicable Not Applicable Not Applicable Not Applic
able Repeating
Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833653
Page 95 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833654
Page 96 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833655
Page 97 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833656
Page 98 of 488
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applica
ble Repeating
Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833657
Page 99 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833658
Page 100 of 488
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryTreatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatment Start Date Form Instance
1.Not Applicab
le Not Applicable Not Applicable Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833659
Page 101 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833660
Page 102 of 488
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
1.Not Applicable Not Applicable Repeating Pages
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833661
Page 103 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833662
Page 104 of 488
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833663
Page 105 of 488
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833664
Page 106 of 488
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833665
Page 107 of 488
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833666
Page 108 of 488
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833667
Page 109 of 488
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833668
Page 110 of 488
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833669
Page 111 of 488
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833670
Page 112 of 488
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833671
Page 113 of 488
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833672
Page 114 of 488
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833673
Page 115 of 488
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Applicable
//Comments
2.Primary Reason for Unblinding: Not Applicable Comments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833674
Page 116 of 488
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833675
Page 117 of 488
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Dec/29/2020
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Pneumonia due to COVID-19]
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833676
Page 118 of 488
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Dec/26/2020
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833677
Page 119 of 488
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833678
Page 120 of 488
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Stephen Grubb Approved Mar-03-2021 12:07:11 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833679
Page 121 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormAug-21-2020 06:21:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833680
Page 122 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Jan-06-2021 10:30:47 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833681
Page 123 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Jan-06-2021 10:31:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833682
Page 124 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-31-2020 11:40:24 (UTC-05:00) Eastern Time
(US & Canada)Low and high levels not provided on report
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833683
Page 125 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-31-2020 11:40:24 (UTC-05:00) Eastern Time
(US & Canada)Low and high levels not provided on report
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833684
Page 126 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-31-2020 11:40:24 (UTC-05:00) Eastern Time
(US & Canada)Low and high levels not provided on report
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833685
Page 127 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-31-2020 11:40:24 (UTC-05:00) Eastern Time
(US & Canada)Low and high levels not provided on report
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833686
Page 128 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-31-2020 11:41:10 (UTC-05:00) Eastern Time
(US & Canada)Low and High levels not given on reports.
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833687
Page 129 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-31-2020 11:41:10 (UTC-05:00) Eastern Time
(US & Canada)Low and High levels not given on reports.
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833688
Page 130 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-31-2020 11:41:10 (UTC-05:00) Eastern Time
(US & Canada)Low and High levels not given on reports.
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833689
Page 131 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-31-2020 11:41:10 (UTC-05:00) Eastern Time
(US & Canada)Low and High levels not given on reports.
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833690
Page 132 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-12-2021 09:46:59 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833691
Page 133 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Jan-13-2021 08:14:42 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833692
Page 134 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aJan-13-2021 08:15:20 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
2.aJan-13-2021 08:14:59 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833693
Page 135 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Deleted
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormJan-12-2021 09:48:55 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833694
Page 136 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Deleted
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2.aJan-12-2021 09:47:23 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833695
Page 137 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-31-2020 12:37:21 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833696
Page 138 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-31-2020 12:37:21 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833697
Page 139 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-31-2020 12:37:21 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833698
Page 140 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-31-2020 12:37:21 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833699
Page 141 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-08-2021 08:39:48 (UTC-05:00) Eastern Time
(US & Canada)NOT APPLICABLE
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833700
Page 142 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Jan-08-2021 08:39:48 (UTC-05:00) Eastern Time
(US & Canada)NOT APPLICABLE
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833701
Page 143 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Jan-08-2021 08:39:48 (UTC-05:00) Eastern Time
(US & Canada)NOT APPLICABLE
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833702
Page 144 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Jan-08-2021 08:39:48 (UTC-05:00) Eastern Time
(US & Canada)NOT APPLICABLE
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833703
Page 145 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Jan-08-2021 08:39:48 (UTC-05:00) Eastern Time
(US & Canada)NOT APPLICABLE
Not Applicable
4Jan-05-2021 08:23:06 (UTC-05:00) Eastern Time
(US & Canada)Not Done
Not Done
4Dec-31-2020 12:22:21 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833704
Page 146 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Jan-08-2021 08:39:48 (UTC-05:00) Eastern Time
(US & Canada)NOT APPLICABLE
Not Applicable
5Jan-05-2021 08:24:29 (UTC-05:00) Eastern Time
(US & Canada)Not Done
Not Done
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833705
Page 147 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Jan-08-2021 08:39:48 (UTC-05:00) Eastern Time
(US & Canada)NOT APPLICABLE
Not Applicable
6Jan-05-2021 08:24:49 (UTC-05:00) Eastern Time
(US & Canada)Not Done
Not Done
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833706
Page 148 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-12-2021 09:46:26 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833707
Page 149 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Jan-12-2021 09:48:17 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833708
Page 150 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Jan-12-2021 09:47:51 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833709
Page 151 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Jan-12-2021 09:48:04 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833710
Page 152 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/25/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Jan-12-2021 09:48:32 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833711
Page 153 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/26/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-11-2021 08:31:25 (UTC-05:00) Eastern Time
(US & Canada)Not Done Patient died on 26Dec2020 and Illness
Convalescent Visit
FormFeb-09-2021 09:51:19 (UTC-05:00) Eastern Time
(US & Canada)Patient died on 26Dec2020 and Illness
Convalescent Visit not done
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833712
Page 154 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: DATE OF VISIT - ILLNESS CONVALESCENT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-10-2021 15:18:25 (UTC-05:00) Eastern Time
(US & Canada)There was no Convalescent visit for the subject
passed away on 26Dec2020
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833713
Page 155 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: DATE OF VISIT - ILLNESS CONVALESCENT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Feb-11-2021 08:31:50 (UTC-05:00) Eastern Time
(US & Canada)Not done
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833714
Page 156 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: DATE OF VISIT - ILLNESS CONVALESCENT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Feb-11-2021 08:32:16 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833715
Page 157 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/26/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-16-2021 10:06:38 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833716
Page 158 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-16-2021 10:06:38 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833717
Page 159 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Feb-16-2021 10:06:38 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833718
Page 160 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Feb-16-2021 10:06:38 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833719
Page 161 of 488
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Feb-16-2021 10:06:38 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833720
Page 162 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-21-2020 11:23:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833721
Page 163 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-21-2020 11:23:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833722
Page 164 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-21-2020 11:23:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833723
Page 165 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-21-2020 11:23:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833724
Page 166 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-21-2020 11:23:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833725
Page 167 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-21-2020 11:23:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833726
Page 168 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Dec-21-2020 11:23:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833727
Page 169 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Dec-21-2020 11:23:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833728
Page 170 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Dec-21-2020 11:23:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833729
Page 171 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Dec-21-2020 11:23:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833730
Page 172 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Dec-21-2020 11:23:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833731
Page 173 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-21-2020 13:29:47 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
FormDec-21-2020 11:42:30 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833732
Page 174 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-21-2020 13:29:47 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833733
Page 175 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-21-2020 13:29:47 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833734
Page 176 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-21-2020 13:29:47 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833735
Page 177 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-21-2020 13:29:47 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
4Dec-21-2020 11:30:48 (UTC-05:00) Eastern Time
(US & Canada)Wrong information
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833736
Page 178 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-21-2020 13:29:47 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833737
Page 179 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-21-2020 13:30:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833738
Page 180 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-21-2020 13:30:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833739
Page 181 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-21-2020 13:30:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833740
Page 182 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-21-2020 13:30:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833741
Page 183 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-21-2020 13:30:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
4Dec-21-2020 11:32:38 (UTC-05:00) Eastern Time
(US & Canada)Wrong information
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833742
Page 184 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-21-2020 13:30:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833743
Page 185 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-21-2020 13:30:57 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833744
Page 186 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-21-2020 13:30:57 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833745
Page 187 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-21-2020 13:30:57 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833746
Page 188 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-21-2020 13:30:57 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833747
Page 189 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-21-2020 13:30:57 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833748
Page 190 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-21-2020 13:30:57 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833749
Page 191 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-21-2020 11:40:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833750
Page 192 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-21-2020 11:40:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833751
Page 193 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-21-2020 11:40:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833752
Page 194 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-21-2020 11:40:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833753
Page 195 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-21-2020 11:40:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833754
Page 196 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-21-2020 11:40:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833755
Page 197 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Dec-21-2020 11:40:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833756
Page 198 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Dec-21-2020 11:40:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833757
Page 199 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Dec-21-2020 11:40:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833758
Page 200 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Dec-21-2020 11:40:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833759
Page 201 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Dec-21-2020 11:40:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833760
Page 202 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-21-2020 11:41:22 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833761
Page 203 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-21-2020 11:41:22 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833762
Page 204 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-21-2020 11:41:22 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833763
Page 205 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-21-2020 11:41:22 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833764
Page 206 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-21-2020 11:41:22 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833765
Page 207 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-21-2020 11:41:22 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833766
Page 208 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Dec-21-2020 11:41:22 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833767
Page 209 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-21-2020 11:41:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833768
Page 210 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-21-2020 11:41:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833769
Page 211 of 488
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-21-2020 11:41:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833770
Page 212 of 488
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-05-2021 09:24:03 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833771
Page 213 of 488
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Jan-05-2021 09:24:03 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833772
Page 214 of 488
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Jan-05-2021 09:24:03 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833773
Page 215 of 488
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-05-2021 09:24:37 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833774
Page 216 of 488
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Jan-05-2021 09:24:37 (UTC-05:00) Eastern Time
(US & Canada)Not applicable
Not Applicable
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833775
Page 217 of 488
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Stephen Grubb Approved Mar-03-2021 12:07:11 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-25-2021 10:38:31 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb Approved Feb-24-2021 16:20:25 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-17-2021 09:40:00 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb Approved Feb-16-2021 17:02:05 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833776
Page 218 of 488
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
By my dated signature below, I, StephenGrubb, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-15-2021 12:18:42 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb Approved Feb-12-2021 14:22:47 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-10-2021 15:10:38 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb Approved Feb-09-2021 11:55:01 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833777
Page 219 of 488
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
N/A Feb-08-2021 13:36:45 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb Approved Jan-29-2021 09:15:07 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-26-2021 14:56:42 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb Approved Jan-24-2021 13:47:34 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-18-2021 08:21:35 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb Approved Jan-15-2021 11:22:32 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833778
Page 220 of 488
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
By my dated signature below, I, StephenGrubb, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-12-2021 09:27:39 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb Approved Jan-11-2021 17:03:14 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-21-2020 13:29:47 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb Approved Dec-21-2020 12:10:18 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833779
Page 221 of 488
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
N/A Dec-21-2020 11:23:21 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb Approved Oct-21-2020 17:20:32 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833780
Page 222 of 488
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-17-2020 22:23:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-17-2020 22:23:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833781
Page 223 of 488
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-17-2020 22:23:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/17/2020Initial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833782
Page 224 of 488
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-17-2020 22:22:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12521010Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-17-2020 22:22:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1939Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-17-2020 22:23:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-17-2020 22:23:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-17-2020 22:23:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833783
Page 225 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-17-2020 22:24:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833784
Page 226 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-21-2020 06:22:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-21-2020 06:22:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-21-2020 06:22:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833785
Page 227 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Sep-02-2020 22:21:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:Hypertension
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-02-2020 22:21:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 22:21:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-02-2020 22:21:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-02-2020 22:21:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833786
Page 228 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-02-2020 22:22:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:Seasonal Aller
gies
Start Date: Apr/18/2018
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-02-2020 22:22:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 22:22:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Seasonal AllergiesInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-02-2020 22:22:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/18/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-02-2020 22:22:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-02-2020 22:23:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Term: VertigoInitial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833787
Page 229 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Start Date: Oct/2/2019
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-02-2020 22:23:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 22:23:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VertigoInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-02-2020 22:23:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-02-2020 22:23:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833788
Page 230 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020 18:30:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020 18:30:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
165.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020 18:30:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-25-2020 18:30:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
63.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020 18:30:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-25-2020 18:30:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.2Initial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833789
Page 231 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.a
Date Location User Value Reason
Aug-25-2020 18:30:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.6
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020 18:30:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020 18:30:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.6Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020 18:30:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-25-2020 18:30:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833790
Page 232 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-21-2020 06:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-21-2020 06:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
230749Initial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833791
Page 233 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 06:23:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 06:23:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 06:23:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-21-2020 06:23:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-21-2020 06:23:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020 06:23:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWG1KInitial Entry
5.a Sample ID
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833792
Page 234 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Aug-21-2020 06:23:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNWG1KInitial Entry
5.b
Date Location User Value Reason
Aug-21-2020 06:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWG1LInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-21-2020 06:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNWG1LInitial Entry
5.c
Date Location User Value Reason
Aug-21-2020 06:24:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYXM0Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-21-2020 06:24:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPYXM0Initial Entry
5.d
Date Location User Value Reason
Aug-21-2020 06:24:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYXM1Initial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833793
Page 235 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.d Sample ID
Date Location User Value Reason
Aug-21-2020 06:24:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPYXM1Initial Entry
5.e
Date Location User Value Reason
Aug-21-2020 06:24:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYXM2Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-21-2020 06:24:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPYXM2Initial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833794
Page 236 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 06:25:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 06:25:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 06:25:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-21-2020 06:25:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-21-2020 06:25:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020 06:25:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYXLZInitial Entry
5.a Sample ID
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833795
Page 237 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Aug-21-2020 06:25:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPYXLZInitial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833796
Page 238 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-25-2020 18:46:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020 18:46:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020 18:46:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-25-2020 18:46:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020 15:44Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020 18:46:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-25-2020 18:46:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833797
Page 239 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Route:
Date Location User Value Reason
Aug-25-2020 18:46:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-25-2020 18:46:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-25-2020 18:46:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833798
Page 240 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-21-2020
02:56:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
ClosedResponse satisfies
query
Sep-18-2020
11:49:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
Answere
dNo e-diary collected
for the subject
Sep-18-2020
04:22:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 2:
OpenedeDiary: Per eDiary
records, VAX 2
eDiary records are
not available for the
subject . Please
confirm in query
response
appropriately.
Sep-07-2020
06:59:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedResponse satisfies
query
Sep-02-2020
22:10:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
Answere
dTranscription Error
Sep-02-2020
22:10:23
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Data Ent
ry:
YES - R
EACTOTranscription Error
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0833799
Page 241 of 488
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US &
Canada)GENICI
TY E-DI
ARY CO
LLECTE
D FOR T
HIS SUB
JECT
Sep-02-2020
05:56:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
OpenedeDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
'No' however VAX 1
eDiary records are
available for the
subject. Please verify
and update. Else,
confirm in query
response
appropriately.
Aug-24-2020
21:08:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
NO - RE
ACTOG
ENICIT
Y E-DIA
RY NOT
COLLEC
TED FO
R THIS
SUBJEC
TInitial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833800
Page 242 of 488
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-08-2020 15:57:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833801
Page 243 of 488
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833802
Page 244 of 488
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NO
2.b Symptom:
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833803
Page 245 of 488
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.c Symptom:
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833804
Page 246 of 488
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833805
Page 247 of 488
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.f Symptom:
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
090177e196ae30e6\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833806
Page 248 of 488
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-08-2020 15:59:45
(UTC-05:00) Easte
…[truncated]